Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary purpose of this study was to evaluate the analgesic effect and safety of hydrocodone/acetaminophen extended release compared to placebo.
This phase 2, multicenter, double-blind (DB), placebo-controlled, randomized withdrawal study compared the analgesic efficacy and safety of hydrocodone/acetaminophen extended release to placebo in subjects with moderate to moderately severe chronic lower back pain (CLBP). Participants met pre-defined criteria at the conclusion of the open-label (OL) Titration Period to proceed to randomization into the double-blind (DB) Maintenance Period of the study. Study drug was given for a total of approximately 5 weeks, which included 2 weeks in OL, 2 weeks in DB, and a 3-day taper. During the OL period, all participants took increasing doses of hydrocodone/acetaminophen extended release until they were taking 2 tablets, twice daily. During the DB period, participants in the hydrocodone/acetaminophen extended release group took 1 hydrocodone/acetaminophen extended release tablet twice daily throughout the 2 weeks, while participants in the placebo group took 1 placebo tablet twice daily.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open-label Hydrocodone/Acetaminophen Extended Release | Experimental | Hydrocodone/acetaminophen extended release, 2 tablets twice daily |
|
| Double-blind Hydrocodone/Acetaminophen Extended Release | Experimental | Hydrocodone/acetaminophen extended release, 1 tablet twice daily |
|
| Double-blind Placebo | Placebo Comparator | Placebo, 1 tablet twice daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hydrocodone/acetaminophen extended release | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Double-blind Baseline in Chronic Lower Back Pain (CLBP) Intensity by Visual Analog Scale (VAS) | The change from the double-blind randomization baseline (DB baseline: the last assessment before first dose in the double-blind period) to the final assessment in pain intensity, assessed using the CLBP Intensity VAS (0 mm = No Pain and 100 mm = Worst Pain Imaginable). Least squares means and standard errors from an ANCOVA model. | Double-blind baseline to Day 29 |
| Measure | Description | Time Frame |
|---|---|---|
| Participant's Global Assessment of Back Pain Status at Final Evaluation | The participant's overall impression of their back pain status was obtained by having the participant answer the question "Considering all the ways your chronic low back pain affects you, how are you doing today?" on a 5-point categorical scale: very good (no symptoms and no limitation of normal activities); good (mild symptoms and no limitation of normal activities); fair (moderate symptoms and limitation of some normal activities); poor (severe symptoms and inability to carry out most normal activities); very poor (very severe symptoms which are intolerable and inability to carry out all normal activities). |
Not provided
Inclusion Criteria:
Adult subjects who have a diagnosis of chronic low back pain of at least 6 month duration
Exclusion Criteria:
Subjects with a history of surgical or invasive intervention
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pedro Quintana Diez, MD | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 54875 | Tucson | Arizona | 85704 | United States | ||
| Site Reference ID/Investigator# 54876 |
Not provided
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Open-label Hydrocodone/Acetaminophen Extended Release | 2 hydrocodone/acetaminophen extended release tablets, twice daily, for 2 weeks. |
| FG001 | Double-blind Hydrocodone/Acetaminophen Extended Release |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Open-label (OL) Period |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug |
|
| Double-blind baseline to Day 29 |
| Participant's Global Assessment of Study Drug at Final Evaluation | The participant's overall impression of the study drug was obtained by having the participant answer the question "How would you rate your overall response to the study medication?" on a 5-point categorical scale: excellent; very good; good; fair; poor. | Double-blind baseline to Day 29 |
| Anaheim |
| California |
| 92801 |
| United States |
| Site Reference ID/Investigator# 54877 | Burbank | California | 91505 | United States |
| Site Reference ID/Investigator# 54873 | Lomita | California | 90717 | United States |
| Site Reference ID/Investigator# 54874 | DeLand | Florida | 32720 | United States |
| Site Reference ID/Investigator# 54866 | Oldsmar | Florida | 34677 | United States |
| Site Reference ID/Investigator# 54879 | Marietta | Georgia | 30060 | United States |
| Site Reference ID/Investigator# 54865 | Valparaiso | Indiana | 46383 | United States |
| Site Reference ID/Investigator# 54782 | Prairie Village | Kansas | 66206 | United States |
| Site Reference ID/Investigator# 54862 | Pasadena | Maryland | 21122 | United States |
| Site Reference ID/Investigator# 54878 | Watertown | Massachusetts | 02472-3930 | United States |
| Site Reference ID/Investigator# 54880 | St Louis | Missouri | 63141 | United States |
| Site Reference ID/Investigator# 54881 | Williamsville | New York | 14221 | United States |
| Site Reference ID/Investigator# 54872 | Cincinnati | Ohio | 45227 | United States |
| Site Reference ID/Investigator# 54863 | Marion | Ohio | 43302 | United States |
| Site Reference ID/Investigator# 54745 | Killeen | Texas | 76543 | United States |
| Site Reference ID/Investigator# 54742 | San Antonio | Texas | 78209-1744 | United States |
1 hydrocodone/acetaminophen extended release tablet, twice daily, for 2 weeks.
| FG002 | Double-blind Placebo | 1 placebo tablet, twice daily, for 2 weeks. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Double-Blind (DB) Period |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | OL Hydrocodone/Acetaminophen Extended Release (Nonrandomized) | 2 hydrocodone/acetaminophen extended release tablets, twice daily, for 2 weeks. These participants enrolled in the study and received at least one dose of study drug during the open-label period; these participants were not randomized and did not progress to the double-blind period. |
| BG001 | DB Hydrocodone/Acetaminophen Extended Release | 1 hydrocodone/acetaminophen extended release tablet, twice daily, for 2 weeks. These participants completed the open-label period (hydrocodone/acetaminophen extended release, 2 tablets twice daily), and were randomized to receive hydrocodone/acetaminophen extended release during the double-blind period. |
| BG002 | DB Placebo | 1 placebo tablet, twice daily, for 2 weeks. These participants completed the open-label period (hydrocodone/acetaminophen extended release, 2 tablets twice daily), and were randomized to receive placebo during the double-blind period. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Double-blind Baseline Chronic Lower Back Pain (CLBP) Intensity VAS | The last assessment using the CLBP Intensity Visual Analog Scale (VAS) (0 mm = No Pain and 100 mm = Worst Pain Imaginable) conducted before the first dose in the double blind period. | Mean | Standard Deviation | scores on a scale |
| ||||||||||||||
| Double-blind Participant's Global Assessment of Back Pain Status | Participant answered the question "Considering all the ways your chronic low back pain affects you, how are you doing today?" on a 5-point scale: very good (no symptoms and no limitation of normal activities); good (mild symptoms and no limitation of normal activities); fair (moderate symptoms and limitation of some normal activities); poor (severe symptoms and inability to carry out most normal activities); very poor (very severe symptoms which are intolerable and inability to carry out all normal activities). Values presented for all participants with double-blind baseline data. | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Double-blind Baseline in Chronic Lower Back Pain (CLBP) Intensity by Visual Analog Scale (VAS) | The change from the double-blind randomization baseline (DB baseline: the last assessment before first dose in the double-blind period) to the final assessment in pain intensity, assessed using the CLBP Intensity VAS (0 mm = No Pain and 100 mm = Worst Pain Imaginable). Least squares means and standard errors from an ANCOVA model. | The analysis of the primary outcome measure included all randomized participants who received at least 1 dose of study drug during the double-blind period (double-blind intent-to-treat) and had at least 1 assessment during the double-blind period. | Posted | Least Squares Mean | Standard Error | scores on a scale | Double-blind baseline to Day 29 |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Participant's Global Assessment of Back Pain Status at Final Evaluation | The participant's overall impression of their back pain status was obtained by having the participant answer the question "Considering all the ways your chronic low back pain affects you, how are you doing today?" on a 5-point categorical scale: very good (no symptoms and no limitation of normal activities); good (mild symptoms and no limitation of normal activities); fair (moderate symptoms and limitation of some normal activities); poor (severe symptoms and inability to carry out most normal activities); very poor (very severe symptoms which are intolerable and inability to carry out all normal activities). | Posted | Number | participants | Double-blind baseline to Day 29 |
|
| |||||||||||||||||||||||||||||||
| Secondary | Participant's Global Assessment of Study Drug at Final Evaluation | The participant's overall impression of the study drug was obtained by having the participant answer the question "How would you rate your overall response to the study medication?" on a 5-point categorical scale: excellent; very good; good; fair; poor. | Double-blind intent to treat population; scores for participants with no post-randomization assessment were excluded from this analysis. | Posted | Number | participants | Double-blind baseline to Day 29 |
|
|
AEs were recorded from the time of study drug administration to 30 days after last dose (total 9 weeks); SAEs were recorded from the time that informed consent was obtained until 30 days following discontinuation of study drug (total 13 weeks).
AEs with onset during the OL period are shown separately from AEs with onset after the first dose of study drug (hydrocodone/acetaminophen extended release or placebo) in the DB period.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Open-label Hydrocodone/Acetaminophen Extended Release | 2 hydrocodone/acetaminophen extended release tablets, twice daily, for 2 weeks. These participants enrolled in the study and received at least one dose of study drug during the open-label period. | 0 | 168 | 70 | 168 | ||
| EG001 | Double-blind Hydrocodone/Acetaminophen Extended Release | 1 hydrocodone/acetaminophen extended release tablet, twice daily, for 2 weeks. These participants completed the open-label period (hydrocodone/acetaminophen extended release, 2 tablets twice daily), and were randomized to receive hydrocodone/acetaminophen extended release during the double-blind period. | 0 | 99 | 7 | 99 | ||
| EG002 | Double-blind Placebo | 1 placebo tablet, twice daily, for 2 weeks. These participants completed the open-label period (hydrocodone/acetaminophen extended release, 2 tablets twice daily), and were randomized to receive placebo during the double-blind period. | 1 | 47 | 8 | 47 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CHEST PAIN | General disorders | MedDRA 14.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| CONSTIPATION | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| NAUSEA | Gastrointestinal disorders | MedDRA 14.1 | Systematic Assessment |
| |
| DIZZINESS | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| SOMNOLENCE | Nervous system disorders | MedDRA 14.1 | Systematic Assessment |
| |
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA 14.1 | Systematic Assessment |
|
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie (prior sponsor, Abbott) | 800-633-9110 |
| ID | Term |
|---|---|
| D006853 | Hydrocodone |
| ID | Term |
|---|---|
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
| Adverse Event |
|
| Other, Unspecified |
|
| Male |
|
| Good |
|
| Poor |
|
| Very Good |
|
|
|